Speakers and Leaders by Track

Regulatory Track

Track Leaders

Session Leaders

Speakers

  • Robert Baum, PhD, Executive Director, Pfizer Inc
  • Ronald Branning, VP Corporate Quality & Complianve, Gilead Sciences
  • Robert Brokamp, Dir Automation Services, Jacobs Engineering Group Inc
  • Gail Burnett, PhD, Sr Dir, Quality Bioanalytical Dev, Genentech Inc
  • Bruce Davis, Principal Consultant, Global Consulting
  • Joseph Famulare, Senior Director, External Influence & Compliance, Genentech Inc
  • John Groskoph, Director, New Products Group, Pfizer
  • Reinhard Hanselka, PE, REA, Principal Chemical Engineer, IES
  • Yukio Hiyama, PhD, Section Chief, Drugs Div, National Institute of Health Sciences
  • William Huitt, Owner/President, W. M. Huitt Co.
  • Steven Kozlowski, MD, Director, Office of Biotechnology, OPS, FDA
  • Brian Lange, PE, Director - Quality Engineering, Merck & Co Inc
  • Jacques Morenas, Assistant Director, AFSSAPS
  • Moheb Nasr, PhD, Dir, Office of New Drug Quality, FDA/CDER/ONDQA
  • Chinmoy Roy, Senior Automation Engineer, Genentech
  • Brian Rubin, Process Engineer, CRB Engineers
  • Thomas Schultz, PhD, Sr Director, Regulatory Sciences, Johnson & Johnson Pharma R&D LLC
  • John Sever, President, Cascade Controls
  • James Spavins, Vice President, Global CMC, Pfizer Inc
  • Richard Zinkowski, Business Development Manager, Burkert Fluid Control Systems

Manufacturing Track

Track Leaders

  • Larry Kranking, President, Aveta Lifesciences, USA
  • Raymond Scherzer, Retired

Session Leaders

Speakers

Facilities Engineering Track

Track Leaders

  • M. James Kimmel, Director of Engineering, Cephalon
  • Thomas Trevithick, VP, Integrated Eng'g Mgmt, Wyeth

Session Leaders

Speakers

  • Patrick Banes, NE Technical Sales Mgr, Astro Pak Corp
  • Anthony Bevilacqua, Director, Research/Development, Mettler-Toledo Thornton Inc
  • Mark Butler, Senior Vice President, IPS
  • Laura Carlson, Senior Associate, RMJM Hillier
  • Nissan Cohen, Industry Sales Mgr, IN USA
  • James Corry, Engineering Ldr, Process Maintenance, Eli Lilly & Co
  • Daniel D'Aquila, PE, Director, Engineering & Validation, GlaxoSmithKline
  • Jim Davis, Construction Manager, Jacobs Engineering Group Inc
  • Katherine Detterline, Commissioning/LEED Admin, Bovis Lend Lease
  • David Dolgin, Sr Quality Program Manager, Abbott Labs
  • Ronald Eiswerth, Associate Principal, RMJM Hillier
  • Roger Emmett, Director of Quality, NA, Praxair Distribution, Inc.
  • Gerald Geisler, Director Global Eng, Bristol-Myers Squibb
  • Michelle Gonzalez, BioPharm Engineering Consultant
  • Robert Graves, AIA, LEED, AP, Chairman of the Board/Principal, Flad Architects
  • Thomas Hartman, Vice President, GMP Operations, GlaxoSmithKline
  • Gary Hedrick, Associate Eng Consultant, Eli Lilly and Company
  • John Hercik, Quality Manager, Praxair, Inc.
  • John Holton, PE, Director of Engineering, Cephalon
  • Terry Jacobs, AIA, Principal, Jacobs/Wyper Architects, LLP
  • Gary Knapick, P.E., Validation Manager, Bristol-Myers Squibb
  • Chad Larrabee, Category Manager, Ingersoll-Rand
  • Garrick Maine, Architect/Project Designer, Flad & Associates
  • Maria Teresa Martinez, Northern Region Quality Mgr, Jacobs Engineering
  • Paul Mathew, Staff Scientist, Lawrence Berkeley Nt'l Lab
  • Dave McGlashan, RA
  • John Murray, PE, Facilities Site Director, Bristol-Myers Squibb
  • Reune Runyon, Global Key Account Manager, Christ Pharma and Life Sciences
  • Christopher Savitz, Operational Excellence Leader, GlaxoSmithKline Biologicals
  • N. Cameron Sipe, Principal Project Engineer, Wyeth Biotech
  • Ed Walczak, Project Manager, AstraZeneca
  • Paul Whitby, Consumer OpU Engineering, Maintenance & Capital Planning Leader, Wyeth
  • David Wilson, Director, Engineering, Abbott Bioresearch Center

Innovation Track

Track Leaders

  • David Selby, PhD, Managing Director, Selby Hope International Ltd
  • Timothy Tyson, Chairman and CEO, Aptuit, Inc.
  • Sion Wyn, Director, Conformity Ltd.

Session Leaders

Speakers

Investigational Products Track

Track Leaders

Session Leaders

Speakers

  • Chedia Abdelkafi, Dir, Clinical Supplies Solutions, N-Side
  • Dale Aldrich, President, Ultramikro, LLC
  • Michael Arnold, RPh, Bus. Process Head, GSC, Pfizer Inc
  • Dave Asher, CEO & President, Asher Associates Inc.
  • Sandra Cook, PhD, Supply Chain Project Manager, AstraZeneca
  • Patricia Dimock, Packaging Coordinator, Pfizer
  • Kathleen Eddeh, Clinical Demand Project Mgr, Schering Plough Corporation
  • Evelyn Ego, Head Global Clinical Supply, Bayer Schering Pharma AG
  • Christine Fattore, Director, CRPS, MedImmune
  • Miguel Feliz, Senior Clinical Supplies Manager, Schering-Plough Corp
  • Dan Giang, Clinical Trials Pharmacist, Almac Clinical Services
  • Mitchell Horoho, CT Materials Associate, Eli Lilly & Co
  • Vickie Johnson, Clinical Trials Pharmacist, Almac Clinical Services
  • Angus MacLeod, Global Depot Manager, Aptuit
  • Linda Manor, RPh, Pharmacist, University of North Carolina Hospitals
  • Michael McNear, VP Innovation Technologies, Fisher Clinical Services
  • Alan Minsk, Partner & Leader, Food & Drug Practice Team, Arnall Golden & Gregory LLP
  • Robert Pizzie, PhD, Senior Director, GCS Planning, Schering-Plough Research Institute
  • Chris Popple, Mgr. Clinical Demand Planning, MedImmune
  • Benjamin Romero, Principal Packaging Engineer, Bristol-Myers Squibb
  • Robert Smith, Dir CPRS QA & QP, Genzyme Ltd
  • Peter Trimboli, Drug Supply Manager, Bristol-Myers Squibb

Project Management Track

Track Leaders

Session Leaders

Speakers

Guides Track

Track Leaders

Session Leaders

Speakers

Notice Regarding Speakers
Speakers selected to present programs are leading professionals in their field. However, in rare circumstances, it may be necessary to make substitutions. Every possible effort will be made to secure a speaker with comparable qualifications. Agendas are subject to change without notice. Every precaution is taken to ensure accuracy, but ISPE cannot accept responsibility for information distributed or contained in the programs or for any opinion expressed.

 

Sponsors